ClinicalTrials.gg
CompletedNCT05518825PREFERUpdated Aug 24, 2023

Assessment of ONS-flavour Preference in Cancer Patients With and Without Taste Alterations

An interventional study of Fortimel/Nutridrink Compact Protein in Oncology and Taste, Altered, sponsored by Nutricia Research. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-24.

Sponsored by Nutricia Research (part of Danone) · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

A single arm intervention study examining ONS-flavour preference in cancer patients with and without taste alterations

02

Conditions studied

  • Oncology
  • Taste, Altered

Keywords

  • Oral nutritional supplement
  • Oncology
  • Taste alterations
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's enrollment of 64 is close to the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Nutricia Research is the lead sponsor of 51 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Being diagnosed with cancer
  2. Undergoing, or having undergone systemic anti-cancer treatment or radiotherapy in the past 12 months.
  3. Age > 18 years
  4. Written

Exclusion criteria

Exclusion Criteria:

  1. Taste and smell alterations not caused by the cancer or anti-cancer treatment
  2. Galactosaemia
  3. Use of thickener to be able to swallow safely
  4. Allergies to any of the product ingredients or any of the flavours
  5. Current prescription for ONS, enteral nutrition or parenteral nutrition
  6. Diabetes mellitus Type I or Type II
  7. Open sores or severe inflammation in the mouth or throat
  8. Undergoing dialysis
  9. Hepatic encephalopathy
  10. Patients with heart failure who have symptoms of heart failure at rest and/or are unable to carry on any physical activity without discomfort
  11. Known pregnancy or lactation
  12. Average alcohol use of > 21 glasses per week for men or > 14 glasses per week for women or drug abuse in opinion of the investigator
  13. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
  14. Participation in any other studies involving food products concomitantly or within two weeks prior to entry into the study.
  15. Employees of Nutricia Research and/or partners, parents, children and brothers/sisters of employees
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Fortimel/Nutridrink Compact Protein

    Twice daily serving of the study product

    Dietary Supplement: Fortimel/Nutridrink Compact Protein

Interventions

  • Dietary supplementFortimel/Nutridrink Compact Protein

    Twice daily serving of the study product

06

What researchers measure

Primary outcomes

  1. Choice for the Fortimel/Nutridrink Compact Protein sensation flavour over the Fortimel/Nutridrink Compact Protein regular flavour

    Subjects take one sensation flavour and one regular flavour and are asked in a direct question which flavour they prefer.

    Time frame: On 4 days

Secondary outcomes

  1. Difference between average liking scores [score 0-10] for Fortimel/Nutridrink Compact Protein sensation flavour range versus Fortimel/Nutridrink Compact Protein regular flavour range

    Time frame: On 4 days

  2. Choice for the Fortimel/Nutridrink Compact Protein sensation flavours over the Fortimel/Nutridrink Compact Protein regular flavours between patients with and patients without Taste and Smell Alterations

    Subjects take one sensation flavour and one regular flavour and are asked in a direct question which flavour they prefer.

    Time frame: On 4 days

  3. Difference in average liking scores [score 0-10] for Fortimel/Nutridrink Compact Protein sensation flavour versus Fortimel/Nutridrink Compact Protein regular flavour between patients with and patients without Taste and Smell Alterations

    Time frame: On 4 days

07

Study locations

1 site
  • Nutricia Clinical Research Unit
    Utrecht, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2022 to primary completion in Mar 2023, 5 months.

Of 75 industry-sponsored interventional studies with no phase under Neoplasms, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 53. This study's 5 months is below that.

Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2022
First posted
Aug 29, 2022
StartActual
Oct 6, 2022
Primary completionActual
Mar 28, 2023
CompletionActual
Mar 28, 2023
Last update
Aug 24, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05518825
Lead sponsor
Nutricia Research
Responsible party
Sponsor
First posted
Aug 29, 2022
Start date
Oct 6, 2022
Primary completion
Mar 28, 2023
Completion
Mar 28, 2023
Last update
Aug 24, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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